Individual Benefits and Harms of Extended Anticoagulation in Patients with Venous Thromboembolism: The VTE-PREDICT Model

M.A. de Winter¹, J.A.N. Dorresteijn², M. Carrier³, A.T. Cohen⁴, J.-B. Hansen⁵, H.A.H. Kaasjager¹, S. Middeldorp⁶, G.E. Raskob⁷, H.T. Sørensen⁸, F.L.J. Visseren², P.S. Wells³, H.R. Büller⁹, M. Nijkeuter¹

¹Department of Acute Internal Medicine, University Medical Center Utrecht, Utrecht, Netherlands, ²Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, Netherlands, ³Department of Medicine, The Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada, ⁴Department of Haematological Medicine, Guys and St Thomas' Hospitals, King's College London, London, United Kingdom, ⁵Department of Clinical Medicine, K.G. Jebsen - Thrombosis Research and Expertice Center (TREC), UiT - The Arctic University of Norway, Tromsø, Norway, ⁶Department of Internal Medicine, Radboud University Medical Center, Nijmegen, Netherlands, ⁷Department of Biostatistics and Epidemiology, Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, United States, ⁸Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark, ⁹Department of Vascular Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands

Abstract Number: OC 57.2

Meeting: ISTH 2021 Congress

Theme: Venous Thromboembolism » VTE Treatment

Background: Deciding to stop or continue anticoagulation for venous thromboembolism (VTE) after initial treatment is challenging as individual risks of recurrence and bleeding are heterogeneous.

Aims: To develop and externally validate a model for prediction of 5-year recurrence- and bleeding risk in patients with VTE who completed an initial anticoagulant treatment of ≥3 months; to illustrate how this model can be applied for estimating absolute benefits and harms of extended anticoagulation in individual patients with VTE.

Methods: Competing risk-adjusted models are derived for prediction of
1) recurrent VTE and
2) clinically relevant, non-major and major bleeding.
Predictors are selected using penalized regression with easily available parameters. The models are derived from combined individual patient data of the Bleeding Risk Study, Hokusai-VTE, PREFER-VTE, RE-MEDY and RE-SONATE. External validity (discrimination, goodness-of-fit) will be assessed using the Danish National Patient Registry, EINSTEIN-CHOICE, GARFIELD-VTE, MEGA study and Tromsø study. Absolute recurrence risk reduction and increase in bleeding risk with extended treatment will be estimated by combining the models with hazard ratios from trials and meta-analyses.

Results: First analyses in 15,283 patients (median age 59 years (IQR46-69); 41% female) indicate that age, sex, BMI, Asian race, PE, proximal versus distal DVT, surgery, trauma or immobilization preceding the index event, history of cancer, stroke, chronic inflammatory disease, history of bleeding, NSAID use, statin use, hemoglobin, platelet count and D-dimer during anticoagulation are predictive of VTE recurrence and/or bleeding. Internal validation showed good calibration (Figure 1). An individual patient example is shown in Figure 2. Final models and results of external validation will be presented.

Internal validation of prediction models for recurrent VTE and bleeding in adult patients with VTE within 6 months (recurrence risk model) and 1 year (bleeding risk model) after initial treatment. Time horizon will be extended in further analyses with additional data.

Patient example of absolute 1-year risks of recurrence and clinically relevant non-major and major bleeding and treatment effect of extended anticoagulation predicted using the VTE-PREDICT model. BMI body mass index; DOAC direct oral anticoagulant; DVT deep venous thrombosis; Hb hemoglobin; VKA vitamin K antagonist

Conclusions: We anticipate that the models can be applied to predict the effect of extended anticoagulation for individual patients with VTE, which can be used to support shared decision-making.
Acknowledgement: We are grateful to the many colleagues whom contributed to this project.

To cite this abstract in AMA style:

de Winter MA, Dorresteijn JAN, Carrier M, Cohen AT, Hansen J-, Kaasjager HAH, Middeldorp S, Raskob GE, Sørensen HT, Visseren FLJ, Wells PS, Büller HR, Nijkeuter M. Individual Benefits and Harms of Extended Anticoagulation in Patients with Venous Thromboembolism: The VTE-PREDICT Model [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1). https://abstracts.isth.org/abstract/individual-benefits-and-harms-of-extended-anticoagulation-in-patients-with-venous-thromboembolism-the-vte-predict-model/. Accessed September 24, 2021.

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